The Impact of a Beach Chair Position During Shoulder Arthroscopy on Regional Cerebral Oxygen Saturation : Comparison of Interscalene Block and General Anesthesia

The aim of this study is to investigate the relationship between the patient positioning in the beach chair position with consequential arterial pressure changes and their influence on regional cerebral oxygen saturation under two anesthesia techniques, general anesthesia in one group of patients and interscalene block in the second group of patients.

Study Overview

• Status: Completed
• Conditions: Impaired Oxygen Delivery; Cerebral Hypoxia

Detailed Description

The participants of the study are patients scheduled for elective shoulder athroscopy. The patients randomise themselves by choosing the type of anesthesia technique (general anesthesia or interscalene block) after detailed description of both techniques. They receive the standard, routine medical care (monitoring and anesthesia techniques) during which the obtained data of arterial pressure, heart rate, peripheral and cerebral oxygen saturation will be statistically analysed and compared.

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients for elective arthroscopy of the shoulder

Description

Inclusion Criteria:

Inclusion criterion for the study was the approval for surgery under general or regional anesthesia with ASA I and ASA II patients classification. -

Exclusion Criteria:

• The patients who have refused to take part in the study, patients assessed as ASA III or higher, who have cerebrovascular or coronary disease, coagulopathy, hypersensitivity to local anesthetics or other contraindications to one or the other type of anesthetic techniques All patients in whom the operation lasted less than 20 minutes or longer than 90 minutes, have been also excluded from the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
GA; general anesthesia
ISB; interscalene block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in arterial pressure from baseline	baseline, during the operation, one hour after the operation

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in regional cerebral oxygen saturation from baseline	baseline, during the operation, one hour after the operation

Collaborators and Investigators

• Sponsor: Osijek University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 16, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: interscalene block, general anesthesia, shoulder arthroscopy, cerebral oxygen saturation, beach chair position
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Hypoxia, Brain
• Other Study ID Numbers: 25-1:5484-3/2013.